The Office of Research Integrity and Compliance has developed the following templates for use by the Lurie Children’s research community to enroll research participants. For more information on the consent process, please refer to the IRB Policy and Procedure Manual Section 11: Informed Consent.
The following guidance is to be used when writing research consent and assent forms:
Writing that is clear and to the point helps improve communication and takes less time to read and understand. Clear writing tells the reader exactly what the reader needs to know without using unncessary words or expressions. It is important to create a consent form that is effective in summarizing the research in a way that facilitates the understanding of the reasons why one might or might not want to participate.
Informed consent documents should be written at a level appropriate to the subject population, generally at a 6th-8th grade reading level. To test the level of writing and clarity, it may be helpful to read the consent form out loud to a colleague or use the tools in the program Word that can assess the reading level. Always tailor the consent forms to the subject audience, avoid technical jargon or complex terms, and use an active voice.
Regulations require that the informed consent document must include certain basic information and additional optional elements if applicable. The elements of consent are outlined here: Basic and Additional Elements of Consent
The IRB has collected common terms, procedures and their commonly associated risks to use when writing consent forms. The IRB expects that the writer will edit the wording to make it study specific.
Library of Procedures, Terms and Risks (version 2/5/18)
The PRISM Readability Toolkit is a resource that contains plain language to make scientific and medical information more understandable for readers of the informed consent documents.
For studies in which there is greater than minimal risk for participants, the following templates may be used for obtaining consent.
For studies in which there is no more than minimal risk for participants, the following templates may be used for obtaining consent.
The above consent templates include the required elements for obtaining written HIPAA Authorization for the use of Protected Health Information (PHI).
For studies in which there is no more than risk for participants, the following templates may be used for obtaining consent.
For studies in which the requirement of obtaining a signed consent form has been waived by the IRB, use one of the following templates to create an "information sheet" for obtaining consent:
The following IRB approved Short Forms are to be used when an investigator encounters a potential research participant who does not speak or understand the English language and IRB approved full translated consents are not available. If there is a need for a Short Form not present in the list below, the English Template may be translated at firstname.lastname@example.org.
English Template (version 04/07017) for enrollment of English speakiing participants who are unable to read.
If the target population includes Non-English speakers, a translated copy of the consent form will be required. Contact email@example.com for more information about obtaining a translated consent form. Refer to the IRB Policy and Procedure Manual Section 11: Informed Consent for more information.
The following templates are to be used for the administration of an investigational drug or device in a non-research setting (e.g. emergency use, single-patient IND, compassionate use of a device, etc). Refer to the IRB Policy and Procedure Manual Section 8: Investigational Use of Drugs, Biological Products, and Devices for criteria and more information.